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The HALO® System (including HALO® Ablation Catheter model 90-9100 and HALO® Energy Generator model 90-9000) is indicated for use in the coagulation of bleeding and non-bleeding sites in the gastrointestinal tract including but not limited to the esophagus. Indications include Esophageal Ulcers, Mallory-Weiss tears, Arteriovenous Malformations, Angiomata, Barrett's esophagus, Dieulafoy Lesions, Angiodysplasia, Gastric Antral Vascular Ectasia (GAVE) and Radiation Proctitis (RP).

The HALO® Ablation Catheter model 90-9100 operates in conjunction with HALO® Energy Generator model 90-9000. There are no changes to the HALO® Ablation Catheter or HALO® Energy Generator implemented since the devices were cleared by K083737, K062723 and K062441. The product is also identical in principle of operation and energy density to the treatment site with the predicate devices HALO360 Ablation Catheter, Stellartech Coagulation Catheter. HALO® is substantially equivalent in construction with the predicate devices HALO360 Ablation Catheter, Stellartech Coagulation Catheter and Microvasive Gold Probe. The product is similar in performance with Olympus Heat Probe.

The provided 510(k) summary for BARRX's HALO System (K093008) indicates that no new performance testing was conducted for this submission.

The submission focuses on expanding the indications for use for the HALO® Ablation Catheter to include Gastric Antral Vascular Ectasia (GAVE) and Radiation Proctitis (RP) based on the substantial equivalence to previously cleared devices and existing clinical data.

Therefore, the following information cannot be extracted from the provided text as the study described is a review of existing clinical data, not a new performance study with acceptance criteria.

1. A table of acceptance criteria and the reported device performance: Not applicable, as no new performance testing was conducted.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable for new performance testing. The clinical data supporting the expanded indications was "derived from publications and case studies." The provenance details are not specified.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): Not applicable, as no new test set was created with expert-established ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable, as this is not an AI/device assisting human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): For the expanded indications, the clinical data relied upon was from "publications and case studies" which demonstrated the safety and effectiveness of the device when used for GAVE and RP. This implies that outcomes data from these existing sources served as the basis for substantiating safety and effectiveness for these new indications.
8. The sample size for the training set: Not applicable, as no new training set was explicitly mentioned for algorithmic development in this submission.
9. How the ground truth for the training set was established: Not applicable.

Summary of the study that proves the device meets the acceptance criteria (expanded indications):

The submission argues for the substantial equivalence of the HALO® Ablation Catheter for the treatment of GAVE and RP by referencing:

• Technological Identity and Substantial Equivalence: The HALO® Ablation Catheter model 90-9100 is "technologically identical" to its cleared predicate (K083737, K062723). It also highlights substantial equivalence in principle of operation, energy density, construction, and performance with other predicate devices (HALO360 Ablation Catheter, Stellartech Coagulation Catheter, Microvasive Gold Probe, Olympus Heat Probe).
• Clinical Data Review: Clinical data was provided to FDA "to support the changes in the Instructions for Use associated with the use in the coagulation of bleeding sites for the HALO® Ablation Catheter for the treatment of GAVE and Radiation Proctitis." This data "demonstrated that, when used in accordance with those instructions, the HALO® Ablation Catheter used for the treatment of GAVE and Radiation Proctitis respectively is at least as safe and effective as the cleared HALO® Ablation Catheter for the treatment of bleeding sites in the gastrointestinal tract."
• Basis of Clinical Data: The clinical data supporting the additional indications (GAVE and RP) was "derived from publications and case studies" and facilitated "Physician's Instructions recommending specific treatment settings and selection criteria for the patients (Contraindications, Warnings and Cautions)."
• Similarity of Conditions: GAVE and RP are described as being similar to other already indicated bleeding conditions (esophageal ulcers, Mallory-Weiss tears, etc.) in that they are confined to the mucosal layer, associated with hemorrhage, and treated with coagulative therapy.

In essence, the "study" proving the device meets the acceptance criteria for expanded indications was a retrospective review of existing clinical data from publications and case studies, and an argument for substantial equivalence to previously cleared predicate devices for similar applications. No new pre-market performance study with defined acceptance criteria was conducted.

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The HALO360 Energy Generator intended use is for the coagulation of bleeding and non-bleeding sites in the gastrointestinal tract.

The HALO360 Energy Generator is indicated for use in the coagulation of bleeding and non-bleeding sites in the gastrointestinal tract including but not limited to, the esophagus. Indications include Esophageal Ulcers, Mallory-Weiss tears, Arteriovenous Malformations, Angiomata, Barrett's Esophagus, Dieulafoy Lesions, and Angiodysplasia.

The HALO360 Coagulation System consists of the HALO360 Energy Generator model 1100C-115B with a disposable single-use HALO®60 Coagulation Catheter, output cable, and an optional footswitch. The HALO360 Coagulation System performance and mode of operation is substantially equivalent to the already cleared HALO360 Coagulation System, and Stellartech Coagulation System 2.

There are no changes associated to the HALO360+ Coagulation Catheter.

The HALO360 Energy Generator model 1100C-115B is configured with an output cable (model CCC-001B), an optional footswitch (model FS-100B), and a power cord.

There are no changes to the hardware associated to HALO360 Energy Generator cleared by the 510(k) K050831 and K051168. There are minor changes implemented to the software version of the generator.

This submission addresses software changes for HALO360 Energy Generator cleared by the 510(k) K050831 and K051168. These minor changes implemented to the software version of the generator did not raise any new questions of safety or efficacy.

This 510(k) summary describes a device modification, not a study establishing new acceptance criteria or performance. Therefore, most of the requested information regarding acceptance criteria, study design, and performance metrics is not present in the provided document.

The submission focuses on minor software changes to the HALO360 Energy Generator and demonstrates substantial equivalence to previously cleared devices. It confirms that "These minor changes implemented to the software version of the generator did not raise any new questions of safety or efficacy."

Here's a breakdown of what can be extracted from the document based on your request:

1. A table of acceptance criteria and the reported device performance

This information is not provided in the document. The submission states that the differences were evaluated on bench, implying functional testing was performed to ensure the software changes did not negatively impact performance, but specific acceptance criteria and detailed performance results are not reported. The primary claim is substantial equivalence based on the absence of new safety or efficacy questions.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the document. The document refers to "bench" evaluation, which typically involves laboratory testing rather than testing on a "test set" of patient data as might be relevant for AI/diagnostic devices.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not provided in the document. This is not applicable as the submission is about a software update for an electrosurgical generator, not a diagnostic device requiring expert interpretation for ground truth.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not provided in the document and is not applicable for this type of device modification submission.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This information is not provided in the document and is not applicable. The device is an energy generator for coagulation, not an AI-powered diagnostic or assistive tool for human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This information is not provided in the document. This is not directly applicable. The device is a hardware generator with software control, not a standalone algorithm. Its performance is demonstrated through its function, not through an "algorithm only" evaluation in the context of an AI device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

This information is not provided in the document. The ground truth for such a device would typically be its ability to perform its intended coagulation function safely and effectively, which would be assessed through engineering and bench testing, not expert consensus or pathology in this context.

8. The sample size for the training set

This information is not provided in the document. This concept is not applicable as the device is not an AI algorithm that undergoes "training" on a dataset in the conventional sense. The "software changes" were likely developed and tested internally rather than trained on a distinct dataset.

9. How the ground truth for the training set was established

This information is not provided in the document and is not applicable.

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The HALO® Coagulation System intended use is for the coagulation of bleeding and non-bleeding sites in the gastrointestinal tract.

The HALO® Coagulation System is indicated for use in the coagulation of bleeding and non-bleeding sites in the gastrointestinal tract including but not limited to, the esophagus. Indications include Esophageal Ulcers, Mallory-Weiss tears, Arteriovenous Malformations, Angiomata, Barrett's Esophagus, Dieulafoy Lesions, and Angiodysplasia.

The HALO® Coagulation System consists of the HALO90 Energy Generator model 90-9000 with a disposable single-use HALO® Coagulation Catheter, output cable, and a footswitch. The HALO® Coagulation System performance and mode of operation is substantially equivalent to the already cleared HALO® Coagulation System, HALO360 Coagulation System, and Stellartech Coagulation System 2.

The HALO® Energy Generator model 90-9000 is configured with an output cable (model 90-9010), a footswitch (model 90-9020) and a power cord.

The HALO® Coagulation Generator supplies up to 150 watts of radiofrequency power at 460 kHz in a bipolar mode under power control while continuously monitoring and displaying power density, and energy density. Energy density and power are displayed to allow homogeneous energy delivery equivalent to the HALO90 Energy Generator model 1100C-115C.

The provided text is a 510(k) summary for the BARRX Medical's HALO® Coagulation System. This type of submission focuses on establishing substantial equivalence to predicate devices rather than proving safety and effectiveness through clinical trials and detailed acceptance criteria studies.

Therefore, the document does not contain the information requested regarding acceptance criteria studies, such as:

• A table of acceptance criteria and reported device performance.
• Sample sizes (for test or training sets), data provenance, number or qualifications of experts, or adjudication methods for establishing ground truth.
• Information about multi-reader multi-case (MRMC) comparative effectiveness studies or standalone algorithm performance.
• The type of ground truth used or how it was established for training sets.

The submission primarily focuses on demonstrating that the technological characteristics of the new HALO90 Energy Generator are substantially equivalent to previously cleared predicate devices (HALO® Energy Generator model 1100C-115C, HALO360 Energy Generator model 1100C-115B, and Stellartech Coagulation System 2). The "study" mentioned is limited to bench testing to evaluate the differences in the new generator, such as:

• Simplification of the generator and elimination of unused pneumatic systems.
• Changes in hardware for optimum RF power output for the defined impedance range.
• Minor modification of generator software.
• Change of design and manufacturing facility.

The document explicitly states: "All these differences were evaluated on bench and did not raise questions regarding safety and efficacy. Thus the devices are equivalent."

Essentially, for a 510(k) submission, the "acceptance criteria" for the new device are that its performance, as demonstrated through bench testing (and sometimes limited clinical data if significant changes, though not explicitly detailed here), does not raise new questions of safety or effectiveness compared to the predicate device. The "study" proving this is often a comparison of technical specifications and performance characteristics through bench testing.

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